Dash Chiranjeev, Makambi Kepher, Wallington Sherrie F, Sheppard Vanessa, Taylor Teletia R, Hicks Jennifer S, Adams-Campbell Lucile L
Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
Georgetown Lombardi Comprehensive Cancer Center Biostatistics & Bioinformatics Shared Resource, Washington, D.C., United States.
Contemp Clin Trials. 2015 Jul;43:33-8. doi: 10.1016/j.cct.2015.04.015. Epub 2015 May 8.
Metabolic syndrome and obesity are known risk factors for breast cancers. Exercise interventions can potentially modify circulating biomarkers of breast cancer risk but evidence in African-Americans and women with metabolic syndrome is lacking.
METHODS/DESIGN: The Focused Intervention on Exercise to Reduce CancEr (FIERCE) trial is a prospective, 6-month, 3-arm, randomized controlled trial to examine the effect of exercise on obesity, metabolic syndrome components, and breast cancer biomarkers among African-American women at high risk of breast cancer. Two hundred-forty inactive women with metabolic syndrome and absolute risk of breast cancer ≥ 1.40 will be randomized to one of the three trial arms: 1) a supervised, facility-based exercise arm; 2) a home-based exercise arm; and 3) a control group that maintains physical activity levels through the course of the trial. Assessments will be conducted at baseline, 3 months, and 6 months. The primary outcome variables are anthropometric indicators of obesity, metabolic syndrome components, and inflammatory, insulin-pathway, and hormonal biomarkers of breast cancer risk.
The FIERCE trial will provide evidence on whether a short-term exercise intervention might be effective in reducing breast cancer risk among African-American women with comorbidities and high breast cancer risk--a group traditionally under-represented in non-therapeutic breast cancer trials.
NCT02103140.
代谢综合征和肥胖是已知的乳腺癌风险因素。运动干预可能会改变乳腺癌风险的循环生物标志物，但非裔美国人和患有代谢综合征的女性缺乏相关证据。
方法/设计：聚焦运动降低癌症风险（FIERCE）试验是一项前瞻性、为期6个月、三臂随机对照试验，旨在研究运动对乳腺癌高危非裔美国女性肥胖、代谢综合征成分和乳腺癌生物标志物的影响。240名患有代谢综合征且乳腺癌绝对风险≥1.40的不运动女性将被随机分配到三个试验组之一：1）基于设施的监督运动组；2）家庭运动组；3）在试验过程中保持身体活动水平的对照组。评估将在基线、3个月和6个月时进行。主要结局变量是肥胖的人体测量指标、代谢综合征成分以及乳腺癌风险的炎症、胰岛素通路和激素生物标志物。
FIERCE试验将提供证据，证明短期运动干预是否可能有效降低患有合并症和高乳腺癌风险的非裔美国女性的乳腺癌风险——这一群体在非治疗性乳腺癌试验中传统上代表性不足。
NCT02103140。
